institutional (hospital) pharmacies - ipasaipasa.co.za/downloads/ethics and professional...

CCOONNFFIIDDEENNTTIIAALL IINNSSPPEECCTTIIOONN QQUUEESSTTIIOONNNNAAIIRREE TTOO EESSTTAABBLLIISSHH TTHHEE NNAATTUURREE,, EEXXTTEENNTT AANNDD

SSTTAANNDDAARRDD OOFF PPHHAARRMMAACCEEUUTTIICCAALL SSEERRVVIICCEESS IINN

IINNSSTTIITTUUTTIIOONNAALL ((HHOOSSPPIITTAALL)) PPHHAARRMMAACCIIEESS

PLEASE NOTE: The confidentiality of this document may be withdrawn

should the information furnished lead to further investigation(s)

Please refer this questionnaire for special attention:

TTHHEE SSOOUUTTHH AAFFRRIICCAANN PPHHAARRMMAACCYY CCOOUUNNCCIILL,, 559911 BBeellvveeddeerree SSttrreeeett,, AArrccaaddiiaa,, PPrreettoorriiaa,, 00008833;; 4400004400,, AArrccaaddiiaa,, 00000077;; ((001122)) 331199--88550000;; FFaaxx ((001122)) 33119988555599;; eemmaaiill :: ffoouurriiee@@pphhaarrmmccoouunncciill..ccoo..zzaa

Yes No

Encircle or mark applicable number/block with an ‘X’

HOSPITAL

2

((AA)) IINNSSPPEECCTTIIOONN DDEETTAAIILLSS NOTE: Throughout this questionnaire legislative requirements are indicated with an *

1. Language preference for inspection report

1 English

2 Afrikaans

2. Date of inspection

D D M M Y Y Y Y

3. Name of inspector (in block capitals)

Inspector Code

Inspection start time

4. Type of inspection

1 Monitoring

Training 2 Assistants

Training 3 Interns

4 New Premises

5 Disciplinary

6 Follow-up

((BB)) PPHHAARRMMAACCYY DDEETTAAIILLSS

5. Name of hospital (in block capitals)

6. Name of pharmacy (if different) (in block capitals)

7. Pharmacy registration number Y OFFICE

USE ONLY

Pharmacy details confirmed

Inspection cycle

8. Licence number (if applicable)

9. Telephone number(s) ( ) - ( )

-

10. Fax number -

11. E-mail address

12. Postal address 13. Physical address

Postal Code

Street Code

14. What is the nature of the pharmacy?

1 Public/state hospital

2 State subsidised

3 Private hospital

4 Mine hospital

15. How is the hospital classified?

N/A

1 Tertiary/academic

2 Regional hospital

3 District hospital

4 Community Health

Centre or PHC Clinic

5

Psychiatric/ Long-term facility

Private:

Please specify other:

6

16. To whom are services rendered?

1 In-patients

2 Out-patients/Passing trade

3 Clinics/Other hospitals

17. In which province is the pharmacy situated?

1 Eastern Cape

2 Free State

3 Gauteng

4 Kwazulu- Natal

5 Mpumalanga

6 Northern Cape

7 Limpopo

8 North West

9 Western Cape

18. Where is the pharmacy situated?

1 City centre

2 City suburb

3 Small town

4 Rural #

#< 40,000


HOSPITAL

3

((CC)) PPHHAARRMMAACCYY SSTTAAFFFFIINNGG

19. Name of pharmacy owner as registered

Name

Registration Number

20. Name of responsible pharmacist as registered

Office use

21. Name of pharmacist in charge during inspection

Office use

22. Name of (prospective) tutor(s) if applicable

Office use

Office use

Office use

23. How many community service pharmacists are in the employ of the pharmacy? (public health facilities only) (fill in name and number under comments).

24. How many full-time pharmacists are in the permanent employ of the pharmacy? (at least 5 hours per day) (fill in name and number under comments).

25. How many part-time pharmacists are in the permanent employ of the pharmacy? (less than 5 hours per day) (fill in name and number under comments).

26. How many pharmacist interns are undergoing practical training in the pharmacy?

27. How many registered pharmacist’s assistants (basic) work in the pharmacy?

28. How many registered pharmacist’s assistants (post-basic) work in the pharmacy?

29. How many registered pharmacist’s assistants (learner basic) are undergoing practical training in the pharmacy?

30. How many registered pharmacist’s assistants (learner post-basic) are undergoing practical training in the pharmacy?

31. How many unregistered persons performing acts falling within the scope of practice of pharmacists and/or pharmacist’s assistants would require training in order to register as pharmacist’s assistants with the Council?

32. Who does the actual picking of medicines prior to dispensing? Other personnel

1 Registered pharmacist’s

assistant

2 Pharmacist and/or pharmacist intern

3

33. Who hands the medicine to the patient or care-giver?

Porter/driver/ courier

1 Other personnel

2 Registered pharmacist’s

assistant


4

34. How many items prescribed by an authorised prescriber are dispensed per day on average? In-patients:

Out-patients/ passing trade:

Total

35. How many P.I.T. items are dispensed per day on average?

N/A

36. How many surgical items are dispensed/issued per day on average?

N/A

37. How many ethical stock items are dispensed/issued per day on average?


HOSPITAL

4

((DD)) RREEGGIISSTTRRAATTIIOONN DDEETTAAIILLSS

N/A

Doe

s no

t co

mpl

y

Part

ially

co

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ies

Com

plie

s

38. The name of the responsible pharmacist is displayed conspicuously over the main entrance of the pharmacy.

1

2

3

39. The name of the pharmacist(s) on duty is/are displayed conspicuously in/or outside the pharmacy for the purpose of identification of such person(s) by the public.

1

2

3

40. The pharmacist(s) on duty is/are wearing a nametag or badge indicating his/her name and designation for the purpose of identification of such person(s) by the public.

1

2

3

41. The pharmacy is under the constant personal supervision of a pharmacist.

1

2

3

42. A currently valid annual registration card(s) is available for the pharmacist(s) (refer questions 20, 21, 23,24 and 25).

1

2

3

43. A currently valid annual registration card(s) is available for the pharmacist’s assistant(s) (basic/post-basic) (refer questions 27 and 28).

N/A

1

2

3

44. A currently valid annual registration card(s) is available for the pharmacist’s assistant(s) (learner basic/learner post-basic) (refer questions 29 and 30).

N/A

1

2

3

45. A currently valid certificate for the recording of the pharmacy is available.

N/A

1

2

3

Comments and/or corrective action required for all items marked ‘does not comply’ or only ‘partially complies’


HOSPITAL

5

((EE)) PPRREEMMIISSEESS AANNDD LLAAYYOOUUTT

N/A

Doe

s no

t co

mpl

y

Part

ially

co

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Com

plie

s

46. The premises are clean.

1

2

3

47. The premises are orderly and tidy.

1

2

3

48. The pharmacy is suitably located in the institution.

1

2

3

49. The pharmacy is accessible to persons with disabilities. 1 2 3

50. The floor surface in the dispensing area is of impermeable material. 1 2 3

51. All working surfaces are finished with a smooth, impermeable and washable material.

1

2

3

52. Countertops are finished with a smooth, impermeable and washable material which is easy to maintain and in a hygienic condition.

1

2

3

53. Shelves are finished with a smooth, impermeable and washable material which is easy to maintain and in a hygienic condition.

1

2

3

54. Walls are finished with a smooth, impermeable and washable material which is easy to maintain and in a hygienic condition

1

2

3

55. Approval has been obtained from Council in the event that a person who is not registered with Council conducts a separate practice/business within the pharmacy (Ethical Rule 13(a)).

N/A

1

No

3

Yes

56. The lighting is suitable and effective.

1

2

3

57. The temperature in the pharmacy is below 25°C (as checked with a thermometer).

1

2

3

58. The temperature in the pharmacy is controlled 24 hours a day as demonstrated by a maximum/minimum thermometer.

1

2

3

59. There is an air conditioner in the pharmacy and is in good working condition.

1

2

3

60. The temperature is recorded on a daily basis.

1

2

3



HOSPITAL

6

PPRREEMMIISSEESS AANNDD LLAAYYOOUUTT((CCoonnttiinnuueedd))

N/A

Doe

s no

t co

mpl

y

Part

ially

co

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Com

plie

s

61. There is at least one fire extinguisher or fire hose in the pharmacy. 1

2

3

62. If there is a fire extinguisher, it has been serviced within the last year (as indicated on the cylinder)

1

2

3

63. The electrical equipment is regularly maintained and safe. 1

2

3

64. The dispensing surface area is sufficient for the volume of prescriptions dispensed (a clear working surface area of at least 90cm to 1m must be provided for each pharmacist or other person(s) registered with Council who work in the dispensary).

1

2

3

65. The total floor area is sufficient for the efficient operation of dispensary staff. 1 2 3

66. The workflow in the pharmacy is efficient. 1 2 3

67. There is a suitable waiting area, which is under cover. No out-patients

1 2 3

68. The waiting area is situated near the dispensary area, areas for counselling and the furnishing of information and/or consultation areas.

1 2 3

69. The waiting area has comfortable seating available/provided.

1 2 3

70. There is a suitable semi-private area for the provision of information and advice, in accordance with GPP standards.

N/A

1

2

3

71. There is a suitable private area for the provision of information and advice, in accordance with GPP standards.

1

2

3

72. There is a suitable consultation area for the provision of screening and monitoring test.

1

2

3

73. The professional image of the dispensing area is not affected by the display of commercial material not directly linked with health.

N/A

1

2

3

74. Medicinal and non-medicinal products are displayed separately in the pharmacy.

N/A

1

2

3



HOSPITAL

7

PPRREEMMIISSEESS AANNDD LLAAYYOOUUTT((CCoonnttiinnuueedd))

N/A

Doe

s no

t co

mpl

y

Part

ially

co

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ies

Com

plie

s

75. Key, key card or other device or the combination of any device, which allows access to a pharmacy when it is locked, is kept in person of the responsible pharmacist or the person of another pharmacist at all times.

1

2

3

76. Only the pharmacist(s) has keys to the pharmacy area where schedules 1–6 items are kept.

1

2

3

77. Control of access to pharmacy premises, which include the design and layout of the pharmacy is of such a nature that only registered pharmacy personnel have direct access to medicine.

1

3

3

78. There is sufficient security to prevent unauthorised access to medicines. 1 2 3

79. The pharmacy is designated as a non-smoking area. 1 2 3

80. There is a separate facility for washing hands.

N/A

1

2

3

81. There is a separate facility for cleaning of equipment.

N/A

1

2

3

82. There is a separate service area for outpatients.

1

2

3

83. There is a separate service area for staff.

1 2 3

84. There is a suitable separate facility that comply with GMP standards where compounding is carried out.

1

2

3

85. There is a suitable separate facility that comply with GMP standards where pre-packaging is carried out

1

2

3




HOSPITAL

8

(F) EQUIPMENT

N/A

Doe

s no

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y

Par

tially

co

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Com

plie

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The pharmacy has:

86. - adequate pestles and mortars.

N/A

1

2

3

87. - adequate spatulas.

N/A

1

2

3

88. - a suitable mass meter for dispensing.

N/A

1

2

3

89. - adequate graduated measures.

1

2

3

90. - adequate medicine containers for the dispensing of medicines.

1

2

3

91. - adequate warning labels or clearly noticeable warning indications on the label.

1

2

3

92. - suitable laminar flow cabinet(s) for preparation of parenteral fluids/TPN (e.g. antibiotics) which is validated.

N/A

1

2

3

93. -suitable laminar flow cabinet(s) (vertical) for preparation of biohazardous preparations (e.g. cytotoxics) which is validated.

N/A

1

2

3

94. - sufficient counting apparatus for tablets and capsules.

1

2

3

95. Counting trays are cleaned in order to prevent cross-contamination.

1

2

3

96. All the equipment in the pharmacy is clean. 1

2

3

97. All the equipment in the pharmacy is in good working order. 1

2

3

98. The pharmacy has suitable refuse receptacles (with closing lids where applicable). 1

2

3



HOSPITAL

9

((GG)) SSTTOORRAAGGEE

N/A

Doe

s no

t co

mpl

y

Part

ially

co

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Com

plie

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99. Medicines are stored according to a system.

1

2

3

100. Storage areas are situated so that products are protected from potentially harmful influences.

1

2

3

101. All goods are stored off the floor.

1

2

3

102. Raw materials known to be at risk for cross-contamination are stored separately.

No stock

1

2

3

103. Proper care and control is exercised over hazardous substances (e.g. caustic soda, insecticides etc.) which are stored separately.

No stock

1

2

3

104. Proper care and control is exercised over flammable substances (e.g. ether, methylated spirits etc.) which are stored separately.

No stock

1

2

3

105. A system is in place to ensure effective stock rotation (refer also SOP section).

1

2

3

106. There are no expired medicines on the shelves (as observed).

1

2

3

107. Expired, damaged and/or contaminated stock is clearly separated.

1

2

3

108. Expired, damaged and/or contaminated stock is destroyed in a safe manner (e.g. returned to supplier or waste disposal company) (refer also SOP section and Regulation 27 of Act 101 of 1965).

1

2

3



HOSPITAL

10

SSTTOORRAAGGEE ((CCoonnttiinnuueedd))

N/A

Doe

s no

t co

mpl

y

Part

ially

co

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Com

plie

s

109. Storage area is large enough to allow for orderly arrangement of stock and proper stock rotation.

1

2

3

110. The store is kept locked at all times when not in use (if dedicated bulk pharmacy store).

1

2

3

111. There are no cracks, holes or signs of water damage in the facility.

1

2

3

112. The ceiling is in good condition. 1 2 3

113. The floor is swept daily. 1 2 3

114. Shelves are dusted daily. 1 2 3

115. Walls are clean 1 2 3

116. The storage area is tidy. 1 2 3

117. There are no signs of pest infestations (e.g. cockroaches, rats). 1 2 3

118. Medicines are stored according to a system.

1 2 3

119. Storage areas are situated so that products are protected from potentially harmful influences.

1 2 3

120. All good are stored off the floor.

1 2 3



HOSPITAL

11

STORAGE (Continued)

N/A

Doe

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t com

ply

Part

ially

com

plie

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Com

plie

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121. There is a separate and secure receiving area, which is under cover

1 2 3

122. There is a separate and secure dispatch area, which is under cover.

1 2 3

123. The receiving area is under impermeable cover.

1

2

3

124. The receiving area is effectively separated.

1

2

3

125. Stock is checked on receipt for quantity, quality, damaged containers, type, storage conditions and expiry dates.

1

2

3

126. A list of product types requiring special storage or handling instructions is available and consulted on receipt of stock (refer also SOP section).

1

2

3

127. There is a system for the correct handling of the various types of goods returned from patients, wards, clinics etc. (refer also SOP section).

1

2

3

128. Is any pre-packing performed on the premises? (refer also SOP section).

No

Yes

129. Is pre-packing done in accordance with Regulation 33 of Act 101 of 1965 with regard to temperature, humidity, area and GMP requirements (refer also SOP section).

N/A

1

2

3



HOSPITAL

12

((HH)) CCOONNTTRROOLL OOFF MMEEDDIICCIINNEESS//RREECCOORRDD KKEEEEPPIINNGG

N/A

Doe

s no

t co

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y

Part

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Com

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130. All medicines sold for human use, comply with Regulation 8 of Act 101 of 1965 i.e. labelling requirements.

1

2

3

131. Medicines are purchased only through legally authorised entities/suppliers (as confirmed by pharmacist in charge during inspection).

1

2

3

132. There are no unregistered medicines on the premises (as observed).

1

2

3

133. A computerised programme is used for dispensing.

1 No

3 Yes

134. An effective stock control system is in place.

1

2

3

135. A computerised programme is used for stock control.

1 No

3 Yes

136. Controls are in place for issuing ward stock (refer also SOP section).

N/A

1

2

3

137. Controls are in place for issuing of medicines per patient to the wards (refer also SOP section).

N/A

1

2

3

138. The pharmacist exercises control over medicines kept in places other than the pharmacy (e.g. wards, theatres etc). (refer also SOP section).

N/A

1

2

3



HOSPITAL

13

CCOONNTTRROOLL OOFF MMEEDDIICCIINNEESS//RREECCOORRDD KKEEEEPPIINNGG ((CCoonnttiinnuueedd))

N/A

Doe

s no

t co

mpl

y

Part

ially

co

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ies

Com

plie

s

139. A prescription book/permanent record for S2-S6 medicines is kept as required in Regulation 11(1) of Act 101 of 1965.

1

2

3

140. A prescription record is kept for 5 years as required in Regulation 11(3) of Act 101 of 1965.

1

2

3

141. Original prescriptions are kept in a safe place and are easily retrievable.

1

2

3

142. A patient profile detailing all prescriptions dispensed to the patient is kept for 2 years.

1

2

3

143. A patient profile detailing all P.I.T. dispensed to the patient is kept for 2 years.

N/A

1

2

3

144. S1-S5 medicine are stored/displayed in areas inaccessible to the public.

1

2

3

145. All S1 medicines sales are recorded in a prescription book or other permanent record as required in Regulation 11(2) of Act 101 of 1965.

Not sold

1

2

3

146. All S2 medicine sales are recorded in a prescription book or other permanent record as required in Regulation 11(1) of Act 101 of 1965.

Not sold

1

2

3



HOSPITAL

14


N/A

Doe

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Part

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147. Are S6 medicines ordered, stored or supplied at any time?

No

Yes

148. There is a system in place for the correct handling by the pharmacist of specified S5 and S6 medicines (refer also SOP section).

Not stocked

1

2

3

149. S6 medicines are locked away and the key is under the control of the pharmacist. Not stocked

1

2

3

150. There is an up-to-date register of all specified S5 & S6 purchases and sales as required in Regulation 30 of Act 101 of 1965.

Not stocked

1

2

3

151. The specified S5 and S6 substances register was balanced on the last day of March, June, September and December of each year or within 14 days as required in Regulation 30(2) of Act 101 of 1965.

Not stocked

1

2

3



HOSPITAL

15


152. Does the pharmacy deliver medicines by mail?

1 Yes

2 No

153. Does the pharmacy deliver medicines by courier?

1 Yes

2 No

154. Does the pharmacy deliver medicines by delivery person/porter?

1 Yes

2 No

155. Does the pharmacy deliver medicines by any other means (e.g. train etc.)?

1 Yes

2 No

156. If question 145 was answered ‘yes’, PLEASE SPECIFY by which means:

Such indirect supplies (see questions 119 to 123) comply with all GPP requirements i.r.o. the following:

N/A

Doe

s no

t co

mpl

y

Part

ially

co

mpl

ies

Com

plie

s

157. A control system is implemented that enables detection and correction of a delay in the delivery process.

N/A

1

2

3

158. Medicines are packaged and stored in accordance with registration requirements throughout the delivery process.

N/A

1

2

3

159. Control is exercised so that products are not subjected to unacceptable degrees of heat, cold, sunlight or any other adverse influences during the transportation process.

N/A

1

2

3

160. Medicines prescribed for acute ailments or conditions are not delivered by mail/ courier/train.

N/A

1

2

3



HOSPITAL

16

((II)) TTHHEERRMMOOLLAABBIILLEE MMEEDDIICCIINNEESS

N/A

Doe

s no

t co

mpl

y

Part

ially

co

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Com

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161. Are thermolabile medicines purchased, stored or supplied at any time?

No

2 Yes

162. All thermolabile medicines are stored in a refrigerator.

Not stocked

1

2

3

163. Only medicines are stored in the refrigerator.

Not stocked

1

2

3

164. Medicines are stored in the refrigerator according to a system.

Not stocked

1

2

3

165. The refrigerator is suitable and in good working order.

N/A

1

2

3

166. The refrigerator is connected to a standby generator or other emergency power system to ensure uninterrupted power supply in case of power (current) failure.

1

2

3

167. The refrigerator is fitted with a warning system to indicate that refrigeration has failed or temperatures are above or below 2°C and 8°C.

1

2

3

168. The temperature of the refrigerator is between 2°C and 8°C (as checked with a thermometer).

N/A

1

2

3

169. The temperature of the refrigerator(s) is controlled 24 hours a day as demonstrated by a WHO approved dial thermometer or alcohol or mercury thermometer.

N/A

1

2

3

170. The temperature of the refrigerator is recorded twice daily in accordance with GPP guidelines.

N/A

1

2

3

171. Thermolabile medicines are stored/supplied maintaining the cold chain.

Not stocked

1

2

3

172. If thermolabile medicines are supplied by courier, temperature is being monitored by a WHO approved dial thermometer or alcohol or mercury thermometer from dispatch point to delivery point.

1

2

3



HOSPITAL

17

((JJ)) DDIISSPPEENNSSIINNGG OOFF PPRREESSCCRRIIPPTTIIOONNSS

N/A

Doe

s no

t co

mpl

y

Part

ially

co

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Com

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s

173. Generic substitution is applied in accordance with Section 22(F) of Act 101 of 1965.

1

2

3

174. Dispensed medicine is labelled as required in Regulation 8(4) of Act 101 of 1965. 1

2

3

175. The pharmacist checks the dispensed medicine after it has been labelled and before it is handed or delivered to the patient.

1

2

3

176. The original prescription states who the dispenser was.

1

2

3

177. The final price that the patient pays is indicated on the copy for the payer.

N/A

1

2

3



HOSPITAL

18

((KK)) PPRROOVVIISSIIOONN OOFF PPHHAARRMMAACCEEUUTTIICCAALL CCAARREE

N/A

Doe

s no

t co

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y

Part

ially

co

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Com

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178. The pharmacist obtains all the relevant patient information before dispensing the prescription.

1

2

3

179. The pharmacist evaluates the prescription to identify any possible problems before dispensing the prescription.

1

2

3

180. The pharmacist takes the necessary action if there are any problems with the prescription and/or medicine prescribed.

1

2

3

181. The pharmacist gives advice to the patient or care-giver after the prescription has been dispensed.

1

2

3

182. The pharmacist gives advice to patients who receive OTC medicines.

N/A

1

2

3

183. Advice is given to the patient in a suitable semi-private area.

1

2

3

184. Is a hatch used when providing patient counselling?

No

Yes

185. If a hatch is used, eye contact is possible between the pharmacist and the patient.

N/A

1

2

3

186. If a hatch is used, easy communication is facilitated.

N/A

1

2

3

187. Support aids are used when supplying advice (as observed).

1

2

3

188. Form(s) of support aids used:

0 N/A

Not used

1 Pamphlets/infor-mation leaflets

2 Manufacturers

package inserts

3 Computer printouts

4 Visual aids e.g.

diagrams/posters

5 Please specify

other:

189. Patient information leaflets are available at the dispensary.

1

2

3

190. A procedure is in place for monitoring the patients progress.

1

2

3

191. A pharmacist can be contacted 24 hours a day.

1 No

3 Yes

The pharmacy is open

From

To

And again: From

To

Total hours

open/day

192. Mondays to Thursdays:

193. Fridays:

194. Saturdays:

195. Sundays:

196. Public holidays:


HOSPITAL

19

((LL)) CCOOMMPPOOUUNNDDIINNGG

N/A

Doe

s no

t co

mpl

y

Part

ially

co

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ies

Com

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s

197. The pharmacy performs bulk compounding (e.g. dilution of antiseptic solutions, creams, mixtures etc.) (refer also SOP section).

No

2 Yes

198. TPN/large volume parenterals are prepared in the pharmacy (refer also SOP section).

No

2 Yes

199. Cytotoxic admixtures are prepared in the pharmacy (refer also SOP section).

No

2 Yes

200. IV additives are prepared in the pharmacy (refer also SOP section).

No

2 Yes



HOSPITAL

20

((MM)) WWRRIITTTTEENN SSTTAANNDDAARRDD OOPPEERRAATTIINNGG PPRROOCCEEDDUURREESS There are written standard operating procedures for:

N/A

Doe

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201. good housekeeping (cleaning procedures etc.)

1

2

3

202. pest (insects, rodents etc.) elimination.

1

2

3

203. receipt of stock.

1

2

3

204. effective stock rotation (FEEFO – First entry, expiry, first out).

1

2

3

205. disposal or removal of S1 – S6 expired, damaged and/or contaminated stock as required in Regulation 27 of Act 101 of 1965.

1

2

3

206. product types requiring special storage or handling instructions.

1

2

3

207. separation and handling of goods returned from patients, wards, clinics etc.

1

2

3

208. recall of medicine.

1

2

3

209. delivery of medicines.

N/A

1

2

3

210. a locum/relief pharmacist to be followed regarding the handling of keys, money, etc.

N/A

1

2

3

211. cold chain management (including procedures to be followed in the event of a power failure).

N/A

1

2

3

212. pre-packing (including quality assurance procedures).

N/A

1

2

3

213. compounding operations (including quality assurance procedures).

N/A

1

2

3



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WRITTEN STANDARD OPERATING PROCEDURES (Continued)

N/A

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214. a procedures to be followed regarding the handling of keys, money, etc for a locum or relief pharmacist(s) (where applicable).

1 2 3

215. daily routine and working hours

1 2 3

216. enquiry or complaint procedures.

1 2 3

217. stock-taking 2 1 2 3 2

218. obsolete or unusable stock 2 1 2 3 2

219. storage of medicine 1 2 3

220. procurement of medicine 1 2 3

221. handling of product complaints 1 2 3

222. handling of S5 and S6 medicines 1 2 3

223. preparation of TPN/large volume parenterals (including quality assurance procedures).

N/A

1

2

3

224. oncology mixing (including quality assurance procedures).

N/A

1

2

3

225. preparation of IV additives (including quality assurance procedures).

N/A

1

2

3

226. control over medicines kept in places other than the pharmacy (e.g. wards, theatres etc.) (including controls for issuing ward stock and medicine per patient to the wards)

N/A

1

2

3

227. SOPs are reviewed/updated on a regular basis.

1

2

3



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((NN)) RREEFFEERREENNCCEESS The pharmacy has copies of, or electronic access to:

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228. - one of the last 3 editions of the Martindale.

1

2

3

. - the latest edition of the Good Pharmacy Practice (GPP) Manual.

1

2

3

. - the latest edition of MIMS.

1

2

3

. - a comprehensive textbook on complementary medicine (private sector).

Not Sold

1

2

3

. - the latest edition of Daily Drug Use (Tincture Press Publications) or other Drug Interactions reference source.

1

2

3

. - the latest edition of either MDR or SAMF.

1

2

3

234. - a recent and comprehensive textbook on Pharmacology (not older than 10 years.)

1

2

3

235. a paediatric Dosing Reference Guide. 1 2 3

236. NDOH – Adult Standard Treatment Guidelines for Hospital. 1 2 3

237. NDOH – Paediatric Standard Treatment Guidelines for Hospital. 1 2 3

238. NDOH – Primary Health Care Standard Treatment Guidelines. 1 2 3

239. - a medical dictionary.

1

2

3

240. - a latest copy of the Pharmacy Act, 1974 (Act 53 of 1974) as amended and the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965) as amended.

1

2

3



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((OO)) GGEENNEERRAALL

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241. The pharmacy is designated as a non-smoking area.

1

2

3

242. No medicines are advertised in any way that is contrary to GPP guidelines and Regulation 45 of Act 101 of 1965.

1

2

3

243. A pharmacist has undergone a form of continued education/professional development the last 2 years.

No

In-formal

Formal

244. No arms/ammunition are sold in the pharmacy.

1

2

3

245. No fireworks are sold in the pharmacy.

1

2

3

246. No alcohol, other than for medicinal purposes, is sold in the pharmacy.

1

2

3

247. No tobacco, snuff, cigarettes and tobacco related substances are sold in the pharmacy (this excludes medicinal snuff and anti-smoking aides).

1

2

3

248. Lotto tickets are not sold in the pharmacy.

1

2

3



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((PP)) PPRROOMMOOTTIIOONN OOFF PPUUBBLLIICC HHEEAALLTTHH

249. Are Family Planning services rendered at the pharmacy?

No

Yes

250. Has the pharmacist(s) registered his/her Family Planning qualification with Council?

N/A

1 No

2 Yes

251. Is the necessary Section 22A(15) permit from the Department of Health available for purposes of providing family planning? (previously Section 22A(12))

N/A

1 No

2 Yes

252. Are Primary Care Drug Therapy (PCDT) services rendered at the pharmacy?

No

Yes

253. Has the pharmacist(s) registered his/her Primary Care Drug Therapy (PCDT) qualification with Council?

N/A

1 No

2 Yes

254. If medicines in higher schedules are provided during the provision of PCDT, is the necessary Section 22A(15) permit from the Department of Health available? (previously Section 22A(12))

N/A

1 No

2 Yes

The following services are rendered in accordance with GPP guidelines:

N/A

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255. Blood pressure monitoring.

N/A

1

2

3

256. Pregnancy testing.

N/A

1

2

3

257. Determining of blood sugar levels.

N/A

1

2

3

258. Visiometric determinations.

N/A

1

2

3

259. Audiometric determinations.

N/A

1

2

3

260. Cholesterol screening tests.

N/A

1

2

3

261. Urine analysis screening tests.

N/A

1

2

3

262. Immunisation services (in accordance with National guidelines).

N/A

1

2

3

263. AIDS testing on request from patient (in accordance with National guidelines).

N/A

1

2

3

264. Mother and childcare services N/A 1 2 3

265. Please specify other:

266. The above-mentioned services are rendered in a suitable private area.

N/A

1

2

3

267. Who renders the above services?

N/A No services

rendered

0 Other health care professional

1 Registered Pharmacist’s

assistant


3

4 Please specify other:


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((QQ)) RREECCOOMMMMEENNDDAATTIIOONNSS IINN RREESSPPEECCTT OOFF TTRRAAIINNIINNGG NB: RECOMMENDATIONS MUST ALSO BE MADE IN THE CASE OF MONITORING INSPECTIONS. The inspector must, through his/her observations, take notice of all aspects of pharmacy practice, to give an objective evaluation of the training facilities in the pharmacy and the ability of a prospective tutor to train a pharmacist intern and/or pharmacist’s assistant effectively.

268. A pharmacist intern was trained within the last 3 years.

No

See Comments

Yes

269. A pharmacist’s assistant was trained within the last 3 years.

No

See Comments

Yes

270. Pharmacy: recommended for training?

No

See Comments

Yes

271. Would the pharmacist accept responsibility as a tutor for the training of a pharmacist intern or pharmacist’s assistant?

No

See Comments

Yes

272. Is there evidence that the prospective tutor participates in continuing education/professional development?

No

See Comments

Yes

273. Is there disciplinary action pending against the prospective tutor?

Yes

See Comments

No

274. Is there evidence that the prospective tutor/pharmacist upholds the principles of pharmaceutical care/GPP?

No

See Comments

Yes

275. Tutor: recommended for training?

No

See Comments

Yes

NOTE: Recommendations made by the inspector with respect to training do not necessarily constitute approval for

training by the Council. Final approval of the pharmacy premises and tutor is made by the Council.

Comments and/or corrective action required for all items marked ‘no’ or ‘see comments’


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((RR)) SSIIGGNNAATTUURREESS I, THE UNDERSIGNED, AM FAMILIAR WITH THE CONTENTS OF THIS INSPECTION REPORT. THE RECOMMENDED CORRECTIVE ACTION TO BE TAKEN IN INSTANCES WHERE A QUESTION WAS ANSWERED AS EITHER ‘DOES NOT COMPLY’ OR ‘PARTIALLY COMPLIES’ HAS BEEN EXPLAINED AND WRITTEN IN THIS REPORT, IN EVERY SUCH INSTANCE.

276. Recommended re-inspection

1 Follow-up 3 months

2 Follow-up 6 months

3 Routine

277. Signature of pharmacist in charge during inspection:

278. Name of above pharmacist in charge during inspection (in block capitals) (refer question 21):

279. Signature of inspector:

280. Duration of inspection: (refer inspection start time on page 2) Inspection

end time:

Duration (no. of hours)

FFUURRTTHHEERR CCOOMMMMEENNTTSS

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